100
Participants
Start Date
May 3, 2019
Primary Completion Date
April 1, 2025
Study Completion Date
April 1, 2025
Rituximab
Patients will be intravenously treated with Rituximab 1000mg (or biosimilar) in the first week and receive a 2nd dosage of 1000mg 14 days later. Before every infusion of Rituximab patients will receive intravenous methylprednisolone 100mg together with oral acetaminophen 1000 mg and and intravenous Tavegil 2 mg. At any time during the study, a rituximab biosimilar is allowed as a substitute for the bio-originator rituximab.
endoxan
Patients will be intravenously treated with a total of 6 infusions of cyclophosphamide 500mg every 2 weeks. Before every infusion of cyclophosphamide patients will receive intravenous granisetron to prevent nausea.
Methylprednisolone
Patients are given 1-3 pulses of 500mg methylprednisolone i.v. up to a maximum cumulative dose of 3000mg, taking into account any doses of intravenous methylprednisolone administered within 12 weeks prior to screening.
Prednisolone
after intravenous pulse methylprednisolone, oral prednisolone will be given at a dose of 1mg/kg daily and tapered according to the recommendations
RECRUITING
Leiden University Medical Center, Leiden
NOT_YET_RECRUITING
Noordwest Ziekenhuisgroep, Alkmaar
RECRUITING
Meander Medical Center, Amersfoort
NOT_YET_RECRUITING
HagaZiekenhuis, The Hague
Leiden University Medical Center
OTHER